drugset / Trial / NCT01232504
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
Phase 4
Completed
206 enrolled
Xiamen Amoytop Biotech Co., Ltd.
Shanghai Jiao Tong University Affiliated First People's Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.
Timeline
- Start
- 2009-09
- Primary completion
- 2013-03
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 2 ug/kg | Subcutaneous |
| Comparator | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 3 ug/kg | Subcutaneous |
| Comparator | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Comparator | Granulocyte colony-stimulating factor | Protein / enzyme biologic | 7 ug/kg | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | 2 ug/kg | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | 3 ug/kg | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | 7 ug/kg | Subcutaneous |